For three years, the TruDi Navigation System, an AI-enabled surgical tool developed by Acclarent, a Johnson & Johnson subsidiary, has been used in operating rooms after FDA approval. Initially promising increased precision and safety, the tool’s performance has been mixed, with reports of botched surgeries and misidentified body parts. An extensive Reuters investigation revealed at least 100 malfunction reports, including 10 injuries, since AI integration, compared to only seven malfunction reports prior. Notably, two Texas lawsuits cite strokes resulting from alleged miscalculations near critical arteries during routine procedures. The FDA has approved over 1,300 AI medical devices, with a concerning review highlighting 60 linked recalls shortly after authorization. Hospitals struggle to adapt as regulations lag behind rapid AI advancements, raising questions about the safety and reliability of these technologies. Manufacturers frequently deny responsibility, despite mounting evidence of AI-related issues in medical devices, including ultrasound and heart monitoring systems.
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